Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
F. Walter Hanel GmbH · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954945 | HANEL MAVIG MONITOR SUSPENSION SYSTEM | F. Walter Hanel GmbH | 1996-01-29 | 91 | 0 |
| K945238 | MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6 | F. Walter Hanel GmbH | 1994-12-15 | 49 | 0 |
| K934206 | MAVIG ANGIO SHIELD MODELS 6290 & 6272 | F. Walter Hanel GmbH | 1993-10-07 | 38 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda